| CTRI Number |
CTRI/2025/11/097501 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Yoga & Naturopathy
Diagnostic
Preventive
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of Pranayam and Ayurvedic Medicine in Asthma patients. |
|
Scientific Title of Study
|
Comparative study on the effects of Pranayam and Ayurvedic Medicine in patients of Bronchial Asthma. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VIDYA KIRAN |
| Designation |
PhD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8840624799 |
| Fax |
|
| Email |
kiranvidya2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rajendra Prasad |
| Designation |
Professor and Head |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9411471910 |
| Fax |
|
| Email |
rajendraprasad051@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VIDYA KIRAN |
| Designation |
PhD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8840624799 |
| Fax |
|
| Email |
kiranvidya2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Chikitsalaya Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi |
|
|
Primary Sponsor
|
| Name |
Department of Kayachikitsa |
| Address |
Faculty of Ayurveda
Institute of Medical Science
Banaras Hindu University
Varanasi 221005 Uttar Pradesh India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| VIDYA KIRAN |
Sir Sunderlal Hospital |
Kayachikitsa Department OPD Room No 21 Friday and Room No 22 Wednesday
Faculty of Ayurveda Institutes of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH |
8840624799
kiranvidya2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute of Medical Sciences Banaras Hindu University Varanasi 221005 India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers and diseased patients |
| Patients |
(1) ICD-10 Condition: J452||Mild intermittent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group
Ayurvedic Medicine only |
Only Ayurvedic Medicine Standard care of treatment will given for 90 days
Pranayam will not be given in this group |
| Intervention |
Experimental Group Yog as Pranayam with Ayurvedic Medicine |
Pranayam with Ayurvedic medicine Standard Care of treatment given for 3 month or 90 days Pranayam for 15 days will given 8 min and next 15 days 15 min Next 15 days will given 25 min and next 15 days 30 min Again for next 15 days will given 40 min and last next for 15 days will given 45 min |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
The following Asthma patients will be included as subjects under this research
Non smoking patients receiving Ayurvedic treatment at the OPD of the Kayachikitsa Department of Sir Sunderlal Chikitsalaya Varanasi
Male and Female patients between the age of 20 years to 55 years
Patients suffering from mild to moderate respiratory problems
Person willing to participate in the research work presented
The total disease duration should be 1 to 5 years |
|
| ExclusionCriteria |
| Details |
Male and Female patients below 20 years of age and above 55 years of age
Those respiratory patients who are suffering from any chronic serious disease
Patients suffering from severe respiratory problems
Patients with total disease duration less than 1 year and more than 5 years |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Fatigue
2 Cold and Cough
3 Less Vital Capacity
4 Less or Overweight
5 High BP and High Pulse
6 High Shwasan dar prati minute
7 Shram Janya Shwans Krishrata
8 Blood Test TLC DLC Hemoglobin ESR
|
3 month or 90 days study with follow up of every 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assesment of Objective and subjective criteria by BP Pulse Weight Blood Test Oxymeter Resipyrometery MMRC Breathlessness Scale Kumbhak Shram Janya Shwans Krishrata Shwasan dar prati minute Asthma Control Test.
Effect of Pranayam on Asthma will scientifically approve and will made useful in the view of economy. |
3 Month or 90 days study with follow up of every 15 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an Interventional study on patients with Asthma. No of 100 patient diagnosed with Asthma who meet the inclusionn criteria will be randomly allocated in to two groups A and B. Group A Experimental group and Group B Control Group. Number of 50 patients in Group A and 50 patients in Group B. The duration of study will be 3 month or 90 days with 6 follow ups every 15 days. Data will be collected from OPD of Sir Sunderlal Chikitsalaya Kayachikita Department IMS BHU Varanasi UP. Intervention of Group A will be Pranayam with Ayurvedic medicine and Control Group B will be Ayurvedic medicine only. The purpose of this study is to check the effect of Pranayam with and without Ayurvedic Medicine on Asthma patients. |